Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Randomized Controlled Study of Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis in Liver Cirrhosis: A Pilot Study
Spontaneous bacterial peritonitis (SBP) is a serious infection that occurs in patients with liver cirrhosis and ascites and is associated with substantial morbidity and mortality. Current clinical practice often includes follow-up paracentesis approximately 48 hours after starting antibiotic treatment to assess the change in the ascitic fluid polymorphonuclear leukocyte (PMN) count. However, it remains uncertain whether routine follow-up paracentesis improves clinical outcomes compared with a strategy based primarily on clinical response.
This pilot randomized controlled trial will evaluate whether routine follow-up paracentesis is necessary in patients with cirrhosis and SBP. A total of 40 adult patients with SBP will be randomly assigned in a 1:1 ratio to either a routine follow-up paracentesis group or a no-routine follow-up paracentesis group. All participants will receive standard antibiotic therapy and intravenous albumin according to the study protocol.
Participants assigned to the routine follow-up paracentesis group will undergo repeat paracentesis approximately 48 hours after initiation of antibiotic therapy. Ascitic fluid PMN counts and other laboratory findings will be assessed, and antibiotic treatment may be modified according to the treatment response. Participants assigned to the no-routine follow-up paracentesis group will be monitored using clinical symptoms, vital signs, and blood inflammatory markers without scheduled repeat paracentesis. However, paracentesis may be performed at any time if clinically indicated, such as in the presence of worsening abdominal symptoms, persistent fever, or hemodynamic instability.
The study will compare clinical outcomes between the two treatment strategies, including 30-day and 90-day survival, treatment response, duration of antibiotic therapy, length of hospital stay, SBP recurrence, complications, new infections, and medical costs. The results of this pilot study are intended to provide preliminary evidence for determining whether routine follow-up paracentesis can be safely avoided in selected patients with SBP and to inform the design of a larger randomized controlled trial.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Eun-chae Yoo, CRC(Clinical research coordinator)
- 电话号码：+82-62-220-6216
- 邮箱：karenaec5@daum.net
学习地点
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Gwangju
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Gwangju、Gwangju、韩国、61469
- 招聘中
- Chonnam National University Hospital
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接触：
- Jae Hyun Yoon, Assistant Professor, M.D., Ph.D.
- 电话号码：+82-62-220-6216
- 邮箱：zenmake14@gmail.com
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Adults aged 18 years or older
- Diagnosis of liver cirrhosis based on clinical, histologic, or imaging findings
- Diagnosis of spontaneous bacterial peritonitis confirmed by an ascitic fluid polymorphonuclear leukocyte (PMN) count of ≥250 cells/mm³ at initial paracentesis
- Ability and willingness to provide written informed consent
Exclusion Criteria:
- Suspected secondary bacterial peritonitis, including suspected perforation of a gastrointestinal organ
- Inability to safely undergo paracentesis, defined as platelet count <20,000/mm³ or prothrombin time international normalized ratio (PT-INR) >3.0
- Active bleeding or shock
- Expected survival of less than 48 hours
- Pregnancy or breastfeeding
- Previous ascitic fluid or blood culture demonstrating resistance to cefotaxime or ceftriaxone
- Any other condition that, in the investigator's judgment, would prevent adherence to the study protocol
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：A (Routine Follow-up Paracentesis)
Routine follow-up paracentesis approximately 48 hours after initiation of antibiotic therapy. |
Participants assigned to the routine follow-up paracentesis arm will undergo repeat paracentesis approximately 48 hours after initiation of antibiotic therapy for spontaneous bacterial peritonitis. Ascitic fluid will be analyzed for polymorphonuclear leukocyte (PMN) count, bacterial culture and antimicrobial susceptibility, and biochemical parameters. If the ascitic fluid PMN count has not decreased by at least 25% from baseline, antibiotic therapy may be escalated according to the study protocol. Standard antibiotic therapy and intravenous albumin will be administered according to the study protocol. |
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有源比较器：B (No Routine Follow-up Paracentesis)
No routine follow-up paracentesis; paracentesis will be performed only when clinically indicated. |
Participants will not undergo scheduled follow-up paracentesis at approximately 48 hours. Treatment response will be assessed based on clinical symptoms, vital signs, and blood inflammatory markers. Paracentesis may be performed if clinically indicated, such as for worsening abdominal symptoms, persistent fever, or hemodynamic instability. Standard antibiotic therapy and intravenous albumin will be administered according to the study protocol. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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30 Day Overall Survival
大体时间：30 days after randomization
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The proportion of participants who are alive at 30 days after randomization. Survival status will be assessed during hospitalization or through outpatient follow-up or telephone contact after discharge. |
30 days after randomization
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90 Day Overall Survival
大体时间：90 days after randomization
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The proportion of participants who are alive at 90 days after randomization. Survival status will be assessed during hospitalization or through outpatient follow-up or telephone contact after discharge. |
90 days after randomization
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Length of Hospital Stay
大体时间：From hospital admission to discharge, assessed up to 90 days
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Total number of days from hospital admission to discharge. |
From hospital admission to discharge, assessed up to 90 days
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Antibiotic-Related Adverse Events
大体时间：Through index hospital discharge, assessed up to 90 days
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The proportion of participants experiencing antibiotic-related adverse events, including Clostridioides difficile-associated diarrhea, drug allergy, or anaphylaxis. |
Through index hospital discharge, assessed up to 90 days
|
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Duration of Antibiotic Therapy
大体时间：From initiation of antibiotic therapy to discontinuation or hospital discharge, assessed up to 90 days
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Total number of days of systemic antibiotic treatment administered for spontaneous bacterial peritonitis during the index hospitalization. |
From initiation of antibiotic therapy to discontinuation or hospital discharge, assessed up to 90 days
|
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Recurrence of Spontaneous Bacterial Peritonitis
大体时间：Up to 90 days after randomization
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The proportion of participants who develop recurrent spontaneous bacterial peritonitis within 90 days after randomization. |
Up to 90 days after randomization
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New Infection During Hospitalization
大体时间：Through index hospital discharge, assessed up to 90 days
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The proportion of participants who develop a new infection other than the initial episode of spontaneous bacterial peritonitis during the index hospitalization. |
Through index hospital discharge, assessed up to 90 days
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Cirrhosis-Related Complications
大体时间：Up to 90 days after randomization
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The proportion of participants who develop major cirrhosis-related complications, including hepatorenal syndrome or clinically significant bleeding, during follow-up. |
Up to 90 days after randomization
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Medical Costs
大体时间：Total direct medical costs (in Korean Won or USD) incurred during the index hospitalization, including costs associated with paracentesis, laboratory testing, antibiotic treatment, and other inpatient care, as assessed from hospital billing records.
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Total medical costs incurred during the index hospitalization, including costs associated with paracentesis, laboratory testing, antibiotic treatment, and other inpatient care. |
Total direct medical costs (in Korean Won or USD) incurred during the index hospitalization, including costs associated with paracentesis, laboratory testing, antibiotic treatment, and other inpatient care, as assessed from hospital billing records.
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
De-identified individual participant data collected during the study, including data dictionaries, will be shared upon reasonable request directed to the principal investigator.
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